Corneal implant applicators

ABSTRACT

Devices and methods for handling and depositing corneal implants onto corneal tissue. Devices and methods for packaging and storing corneal implants.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/657,650, filed Oct. 22, 2012, now U.S. Pat. No. 8,668,735, whichapplication is a continuation-in-part of U.S. application Ser. No.13/443,696, filed Apr. 10, 2012, now U.S. Pat. No. 9,005,280, which is acontinuation of U.S. application Ser. No. 13/206,200, filed Aug. 9,2011, now abandoned, which is a continuation of U.S. application Ser.No. 11/422,815, filed Jun. 7, 2006, now U.S. Pat. No. 7,992,906, whichis a continuation of U.S. application Ser. No. 11/054,639, filed Feb. 9,2005, now U.S. Pat. No. 7,128,351, which is a continuation of U.S.application Ser. No. 10/463,091, filed Jun. 17, 2003, now U.S. Pat. No.6,893,461, which is a division of U.S. application Ser. No. 09/843,547filed Apr. 26, 2001, now U.S. Pat. No. 6,581,993, which is acontinuation-in-part of U.S. application Ser. No. 09/660,371, filed Sep.12, 2000, now U.S. Pat. No. 6,543,610; all disclosures of which areincorporated herein by reference.

U.S. application Ser. No. 13/657,650, filed Oct. 22, 2012, also claimspriority to the following provisional applications: U.S. 61/550,185,filed Oct. 21, 2011; U.S. 61/679,482, filed Aug. 3, 2012; and U.S.61/606,674, filed Mar. 5, 2012; all disclosures of which areincorporated herein by reference.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

BACKGROUND

Corneal implants, such as corneal onlays and corneal inlays, can besmall, delicate medical devices, the storage and/or handling of whichshould be carefully performed to prevent damage to the implants.Additionally, corneal implants can also be transparent, which, inaddition to their small size, can make them difficult to see with theunaided eye.

Devices and methods are needed that allow for easy handling andpositioning of small, delicate corneal implants without damaging theimplant.

SUMMARY OF THE DISCLOSURE

One aspect of the disclosure is a corneal implant applicator apparatus,comprising a corneal applicator member comprising an applicator; acorneal implant support disposed relative to the applicator to form animplant chamber; and wherein the applicator and the corneal implantsupport are adapted such that a corneal implant has a greater preferencefor adhering to the applicator than to the corneal implant support.

In some embodiments the applicator is adapted such that the cornealimplant has a greater preference for adhering to corneal tissue than tothe applicator. The applicator can have a radius of curvature that isgreater than a radius of curvature of an anterior surface of the cornealimplant.

In some embodiments the applicator has at least one openingtherethrough. The corneal implant support can also have at least oneopening therethrough.

In some embodiments the corneal implant support has a surface with acontour different than a contour of a surface of the applicator, andwherein the different contours provide the corneal implant with thegreater preference for adhering to the applicator than to the cornealimplant support. The applicator surface can be smoother than the surfaceof the corneal implant support.

In some embodiments the corneal implant support is adapted to be movedrelative to the applicator to provide access to the corneal implant andallow the corneal implant to preferentially adhere to the applicator.The corneal implant support can be detachably secured to the applicator.The apparatus can further comprise at least one clip adapted todetachably secure the corneal implant support to the applicator.

In some embodiments the apparatus further comprises a fluid disposedwithin the implant chamber.

In some embodiments the corneal implant is made from a hydrophilic, suchas a hydrogel, material.

In some embodiments the applicator and corneal implant support areadapted such that the net adhesive forces between the applicator and thecorneal implant are greater than the net adhesive forces between theimplant support and the corneal implant, whereby the corneal implantwill preferentially adhere to the applicator when the applicator andcorneal implant support are moved relative to one another.

One aspect of the disclosure is a method of depositing a corneal implantonto corneal tissue, comprising providing a corneal implant applicatorapparatus, the apparatus comprising a corneal implant applicator, animplant support disposed relative to the corneal implant applicator toform an implant chamber, and a corneal implant disposed in the implantchamber, moving the implant support relative to the corneal implantapplicator to provide access to the corneal implant and to allow thecorneal implant to preferentially adhere to the corneal implantapplicator rather than the implant support, positioning the cornealimplant applicator such that the corneal implant engages corneal tissue,and moving the corneal implant applicator from the corneal tissue toallow the corneal implant to preferentially adhere to the corneal tissuerather than the applicator, thereby depositing the corneal implant onthe corneal tissue.

In some embodiment moving the implant support relative to the cornealimplant applicator comprises removing a securing element that detachablysecures the implant support to the corneal implant applicator.

In some embodiments the method further comprises wicking away fluid fromwithin the implant chamber, wherein the wicking step occurs prior tomoving the implant support relative to the corneal implant applicator.

In some embodiments the method further comprises, prior to thedepositing step, creating a corneal flap and lifting the corneal flap toexpose the corneal tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1a-3c illustrate an exemplary corneal implant applicatorapparatus.

FIG. 4 illustrates exemplary cohesive forces.

FIG. 5 illustrates exemplary adhesive forces.

FIG. 6 illustrates a liquid suspended within a loop

FIGS. 7-13 illustrate an exemplary corneal implant applicator apparatus.

FIGS. 14A-19 illustrate exemplary moderate and minimal bodies.

FIGS. 19-22 illustrate an exemplary corneal implant applicatorapparatus.

FIGS. 23A-35B illustrate components of an exemplary corneal implantapplicator apparatus.

DETAILED DESCRIPTION

The disclosure relates to devices for one or more of packaging, storing,positioning, and delivering corneal implants such as corneal inlays. Thedevices herein can be used in the movement and positioning of, forexample without limitation, corneal onlays, corneal inlays, cornealreplacements, and contact lenses.

FIGS. 1A-3C illustrate an exemplary embodiment of an implant packagingand handling system 48 adapted to apply a corneal implant to a cornealsurface. Referring to FIG. 1A, system 48 includes implant carrier member80 having a handle 50 extending from implant applicator 58. Implantcarrier member 80 is adapted to detachably couple to implant supportmember 78. As illustrated, implant support member 78 has a handle 52extending from implant support 56.

FIG. 1B illustrates detail “A” shown in FIG. 1A. As illustrated in FIG.1B, fastening carrier member 80 and support member 78 together operablyaligns implant applicator 58 and implant support 56. In this embodiment,the handle portions 50 and 52 are positioned adjacent to one another soas to form a support handle 54 (see FIG. 1A). Concave surface 70 ofapplicator 58 is aligned with convex implant support surface 76 ofimplant support 56. Surface 70 and surface 76 form chamber 88therebetween, which provides a storage space to retain a corneal implanttherein.

FIGS. 2A-2C illustrate views of carrier member 80 (support member 78 notshown for clarity). FIG. 2A illustrates a top view of a portion ofcarrier member 80, showing handle 50 and implant applicator 58. FIG. 2Cshows detail “B” from FIG. 2A. In FIG. 2C, applicator 58 includes adomed portion with upper surface 86 and lower surface 70. Lower surface70 is contoured with a radius of curvature that is greater than theradius of curvature of an anterior surface of the implant that is beingpackaged (not shown for clarity). The difference in the radii ofcurvature is advantageous in assisting with the release of the cornealimplant from applicator surface 70. More particularly, a corneal implantgenerally includes a posterior surface that is adapted to make contactwith corneal bed tissue, and an anterior surface that faces in theanterior direction and is disposed under overlying corneal tissue(whether the implant is inserted under a flap or into a pocket).

In use, applicator surface 70 (on which an implant is retained) is firstpositioned immediately over the corneal bed surface such that theimplant engages the corneal bed tissue. Applicator 58 (and thereforesurface 70) is then lifted away from the corneal bed surface. Theanterior surface of the implant releases from applicator surface 70 andthe posterior surface of the implant remains adhered to the corneal bedsurface. To enhance deposition of the implant onto the corneal bedsurface and prevent the implant from remaining adhered to applicatorsurface 70, applicator surface 70 has a radius of curvature that isgreater than the radius of curvature of the anterior surface of theimplant. Due to the difference in radii of curvature, the anteriorsurface of the implant and applicator surface 70 are not complementary,and thus, are more easily separated. In this manner the corneal implantpreferentially adheres to the cornea over applicator surface 70.

In other embodiments applicator surface 70 has an indented ring orrecessed applicator surface (as is shown in FIG. 12 and indicated bynumeral 29 in U.S. Pat. No. 6,581,993, incorporated by referenceherein). The recessed surface can be circular, thereby allowing asubstantially circular implant to be centrally positioned on applicatorsurface 70.

To further enhance disassociation of the corneal implant from applicatorsurface 70, a plurality of openings 64 are provided through applicatorsurface 70 through which a volume of fluid can be passed to help removethe implant. Alternatively, fluid can be withdrawn through the opening64 from the implant that is disposed on applicator surface 70.Particularly, the openings 64 provide a fluid passage for drawing fluidaway from the implant using a cotton swab, or other absorbent material,that would be positioned against upper surface 86 of applicator 58.Additionally, optional central opening 66 is provided in applicator 58to assist with the proper alignment of the implant and the deposition ofthe implant onto the cornea surface. Specifically, a cannula or likeinstrument can be inserted through central opening 66 to depress andassist the release of the implant from applicator surface 70. Thediameter of central opening 66 is greater than the diameter of openings64. In this way, the user is provided with a central point of reference,which enables the user to align applicator surface 70 with the opticalaxis of the eye, and, thus, properly position the implant.

FIGS. 3A-3C illustrate different views of support member 78 (carriermember not shown for clarity). FIG. 3C illustrates detail “A” from FIG.3B. Support member 78 has handle 52 extending from implant support 56.Implant support 56 comprises platform 82 disposed about an upper supportsurface 76 and an opposing lower surface 90. Lower surface 90 isrecessed relative to the lower surface of the platform portion 82. Uppersurface 76 and lower surface 90 have a plurality of openingstherethrough to facilitate the passage of liquid to and away from theimplant.

As shown in FIG. 3B, support 56 is shown at an angle of 30° relative tohandle 52. It can be advantageous for support 56 to be at an anglerelative to handle 52 between about 30° and about 60°. Similarly, theangle between applicator 58 and handle 50 is generally between about 30°and about 60°. In FIG. 2B the angle is 30°. In some embodiments theangle between handle portions 50 and 52 and platform portions 84 and 82,respectively, is about 45°. It is to be understood that a range ofangles can be used without deviating from the scope of the presentdisclosure.

FIGS. 1B, 2A, and 3A illustrate an exemplary embodiment in which supportmember 78 is detachably connected to carrier member 80. Specifically, asillustrated by FIG. 2A, the carrier member 80 is provided with a pair ofnotches or grooves, 68 a and 68 b. Notches or grooves 68 a and 68 b arelocated on opposite sides of applicator 58. Likewise, support member 78is provided with a pair of notches or grooves, 68 c and 68 d, located onopposite sides of implant support 56. Carrier member 80 can be securelycoupled to support member 78 by aligning notch 68 a with 68 c, and notch68 b with 68 d, and then positioning a fastening element about the twomembers and securely within the aligned notches. FIG. 1B shows elasticband 69, which is placed about members 78 and 80, secured within each ofthe respective notches (68 a-d) to secure members 78 and 80 together ina detachable manner. In alternative embodiments metal or plastic clipsare used to fasten together members 78 and 80. It should be understood,however, that various ways can be utilized to fasten the two memberstogether in a detachable manner without deviating from the scope of thedisclosure.

FIGS. 2B and 3A illustrate an additional optional way to secure members78 and 80 together and such that they can be easily separated to preparethe implant for use. Handle 52 includes slot 74 adapted to receive andinterlock with tab 72 of carrier member 80. Tab 72 extends from thelower surface of handle 50 of carrier member 80. In use, carrier member80 is positioned in overlapping relation to support member 78 such thattab 72 is inserted into slot 74. Once inserted, tab 72 holds carriermember 80 together with support member 78. To provide additionalattachment, band 69 is then placed about implant applicator 58 andimplant support 56, as is described in more detail above. In use, theuser initially removes band 69 or other attachment element from thefastened members 78 and 80. Once removed, the user simply slides handle50 in the direction indicated by arrow 98 shown in FIG. 2A, which isgenerally a proximal direction. In this way, tab 72 slidably disengagesfrom slot 74 and members 78 and 80 are separated. Once separated,carrier member 80 can then be used to deposit the implant onto thecornea surface as set forth above. The proximal portion of handle 50 isalso adapted to be secured to a surgical-style handle or other handledevice to more easily deposit the implant onto the corneal bed surface.

Support surface 76 of implant support 56 is adapted such that theimplant will preferably remain adhered to applicator surface 70 uponseparation of members 78 and 80. In this embodiment support surface 76has a more uneven or rough contour than adjacent applicator surface 70.Applicator surface 70 is provided as a smooth or polished surface. Inthis embodiment, it is not critical that surface 70 be microscopicallysmooth, though it may be. In this embodiment, however, it is importantthat surface 70 be smoother than support surface 76. In this manner,applicator surface 70 has a smoother surface area for directlycontacting and adhering to the lens implant.

Support surface 76 is fabricated so as to have a contour characterizedby minute bumps or rounded portions along surface 76. In someembodiments this contoured surface can be fabricated by manufacturingsupport surface 76 from polypropylene comprising polytetrafluoroethylenebeads embedded in the polypropylene surface. Polytetrafluoroethylene issold under the trade name TEFLON. In this embodiment, the beads maintaintheir general conformation when embedded, which results in surface 76having raised bumps, rounded portions, or the like. Alternatively,support surface 76 can be roughened, etched, notched, scored or made tobe imperfect using any one of molding, stamping or other knownmechanical techniques. Surface 76 is less able to adhere to the surfaceof the implant than is smoother applicator surface 70, and the implantwill preferentially remain adhered to applicator surface 70 uponseparation of the members 78 and 80.

Additionally, the implant can be further directed to remain adhered onapplicator surface 70. For example, system 48 can be removed from astorage container in which system is disposed (not shown). System 48 isturned such that carrier member 80 is facing downwards and supportmember 78 is on top. Next, the user simply places an absorbent materialagainst the top surface 60 of applicator portion 58 so as to draw fluidfrom within chamber 88 through openings 64. As the fluid is drawn awayfrom chamber 88 the implant is lowered to a resting position against theapplicator surface 70.

One or more of the various components of system 48 can be made from apolymer or plastic material. For example, system 48 components could bemade from one or a combination of the following polymers:Polytetrafluoroethylene (sold under the trade name TEFLON),Polypropylene, or Polysulfone (sold under the trade name UDEL).Alternatively, portions of each component member could be made from apolymer or plastic together with a portion comprising stainless steel orother metal or semi-metal. For instance, handle 50 of carrier member 80can be manufactured from stainless steel, and applicator portion 58 canbe manufactured from a polymer material. The handle and applicatorscould then be welded or interlocked together using various knownfabrication techniques. It should also be understood that various otherpolymers or polymer combinations can be utilized without deviating fromthe scope of the present invention.

System 48 is adapted to maintain the corneal implant in a hydratedcondition during storage and shipping. System 48 can be positionedwithin a storage device such as a vial as is described in U.S. Pat. No.6,543,610, incorporated by reference herein. When system 48 is placed ina storage device with fluid therein, the corneal implant is in contactwith a volume of storage fluid. In this way, the implant is containedwithin the chamber 88 and maintained in a hydrated condition by thepassage of fluid through the respective openings 62, 64, and 66.

The corneal implant is packaged within chamber 88 defined by applicatorsurface 70 and carrier support surface 76. The height of this space isdesigned to be sufficiently narrow that the implant remains properlyoriented within chamber 88 during storage and handling conditions. Inthis way, the user simply detaches carrier member 80 from support member78 and deposits the implant to the corneal surface by placing theapplicator surface 70, on which the implant is adhered, directly to thecorneal surface.

The disclosure below describes devices and methods of use that rely atleast partially on surface tension of liquids to control the positioningand/or movement of a corneal implant. The devices can be used in thestorage, packaging, movement, or delivering of the corneal implants.These approaches can be used when the corneal implant is made at leastpartially of hydrophilic material, such as a hydrogel.

Surface tension is the property of liquids that allows the surface of abody of liquid to resist external forces. It is what allows objectsdenser then water, such as small pins and certain insects, to float on aliquid's surface. Surface tension is caused by the cohesive forces of aliquid's molecules. Cohesive forces are the attractive forces betweentwo like molecules. As shown in FIG. 4, an average molecule within abody of liquid has no overall cohesive force acting upon it because itsees cohesive forces from neighboring molecules acting upon it in everydirection. A molecule on the surface, however, only sees cohesive forcespulling it inwards. For very small droplets, the inward force on allsurface molecules causes the droplet to be generally spherical in shape.

Adhesive forces, on the other hand, are those seen between unlikemolecules. For some material combinations, these forces can be greaterthan the cohesive forces of a liquid's molecules. These strong adhesiveforces are the cause of an upward ‘bowing,’ called the meniscus (asshown in FIG. 5), in a liquid's surface where the liquid around the edgeof a container is pulled higher than the rest of the surface by theadhesive forces between the liquid and the container. The adhesiveforces pull up on the surface of the water and are in equilibrium withthe gravitational forces pulling down on the body of liquid.

In the case of liquid suspended within a loop, as shown in FIG. 6,adhesion forces from the loop act on both the top and bottom surfaces ofthe liquid and cohesive forces act across both upper and lower surfaces.These forces are sufficient to hold a liquid within a loop up until theliquid's volume is so great that the gravitational forces overcome thecohesive and adhesive forces.

In the case of a solid, mesh, or other such surface, the adhesive andcohesive forces act in a similar fashion. Many factors, including thetype of material, the type of fluid, and the surface geometry willaffect the strength of the adhesive and cohesive forces.

Exemplary corneal implants that can be stored and used in the followingembodiments are corneal inlays described in U.S. Pub. No. US2007/0203577, filed Oct. 30, 2006, now U.S. Pat. No. 8,057,541, U.S.Pub. No. US 2008/0262610, filed Apr. 20, 2007, and U.S. Pub. No.2011/0218623, filed Sep. 8, 2010, the disclosures of which areincorporated herein by reference. In some embodiments, a “smalldiameter” (i.e., between about 1 mm and about 3 mm) corneal inlay ismade from a hydrogel, that may be primarily fluid. This, as well as theinlay's small size, causes it to behave in somewhat the same way as afluid. The disclosure below makes use of these characteristics of thecorneal implant and the adhesion forces between a fluid and varioussurface geometries. While the disclosure herein focuses on cornealinlays, any corneal implant that exhibits similar properties can be usedas described herein. For example, corneal onlays, at least a portion ofwhich have hydrophilic properties, can be used as described herein.

The devices herein rely on a body's “affinity” for a fluid or an objectwith fluid-like properties (e.g., a hydrophilic corneal implant). Asused herein, a body's “affinity” for the fluid or fluid-like object isinfluenced by the difference between the strength of the net adhesiveforces between the body and the fluid or fluid-like object and thestrength of the net cohesive forces within the fluid or fluid-likeobject. In embodiments herein where there is a substantially constantfluid or fluid-like object (e.g., a hydrophilic corneal inlay), therelative affinities of two bodies for the fluid or fluid-like object isat least partially determined by the relative strengths of the netadhesive forces between the bodies and the fluid or fluid-like object.For example, in an embodiment in which the fluid-like object is ahydrophilic corneal implant, a first body can have a greater affinityfor the implant than a second body when the net adhesive forces betweenthe first body and the implant are greater than the net adhesive forcesbetween the second body and the implant.

The corneal implant will remain adhered to the body with the highest netforce (the sum of the adhesive and cohesive forces).

A first body, referred to herein as a “moderate body,” has a greateraffinity for the fluid or fluid-like object than a second body, referredto herein as a “minimal body.” As used herein in this context, “body”may be used interchangeably with device, component, structure, or othersimilar term to indicate anything with structure. The eye, however, hasa greater affinity for the fluid or fluid-like object than the moderatebody. The different relative affinities can be used to handle the inlayand control the movement of the inlay as it is moved from one surface toanother without a user needing to touch it with a hand or other tool.Factors that influence the relative affinities include one or more of:the type of material, the type of fluid, and the surface geometryincluding surface area.

As used herein, a corneal inlay (e.g., the fluid-like object) has agreater “affinity” for the corneal bed of the eye than it does themoderate body, and at the same time the inlay has a greater affinity forthe moderate body than it does the minimal body. The eye can bedescribed as having a greater affinity for the inlay than both themoderate body and the minimal body. Similarly, the moderate body can bedescribed as having a greater affinity for the inlay than the minimalbody. That is, the affinity between two bodies can be described relativeto either body. That is, for example, the moderate body has a greateraffinity for the inlay than does the minimal body, and thus the inlaywill preferentially adhere to the moderate body over the minimal body.

In some embodiments the storage fluid is water or saline, for example.Water molecules are highly polarized, which provides for attractiveforces with other materials.

A relative comparison of the affinity between each body and the inlaycan be represented by: corneal tissue>moderate body>minimal body. Themoderate and minimal bodies may take on many forms, including, withoutlimitation, meshes, membranes, and/or material with different surfacefinishes or contours.

Due to the differences in affinity between the minimal body and themoderate body, the inlay preferentially remains adhered to the moderatebody. It continues to adhere to the moderate body until exposed to astronger adhesive force. The minimal and moderate bodies can thereforebe any suitable material as long as the adhesive forces between themoderate body and the inlay are greater than the adhesive forces betweenthe minimal body and the inlay. The moderate body has a greater affinityfor the inlay than does the minimal body, and the adhesive properties ofthe materials is a factor influencing those affinities.

FIGS. 7-14D illustrate an exemplary embodiment of an apparatus thatcomprises a moderate body and a minimal body, wherein the apparatus alsoincludes an actuation mechanism that is used to separate the minimalbody from the corneal implant and the moderate body. The apparatus canbe used to store the corneal implant, prepare the corneal implant fordelivery, and/or deliver the corneal implant onto or into the eye. FIGS.7 and 8 (side view and sectional side view, respectively) illustratedevice 100 including handle 112 secured to distal portion 114. Actuator116 is disposed in both handle 112 and distal portion 114, both of whichare adapted to allow actuator 116 to pass therethrough. Spring 126maintains actuator 116 in the at-rest, or non-actuated, configurationshown in FIGS. 7 and 8. Actuator 116 has a distal section 128 with areduced size that is disposed in a smaller sized distal channel indistal portion 114.

The distal end of apparatus 100 includes first portion 118 secured tomoderate body 122. A second portion 120 is secured to minimal body 124and is also detachably secured to first portion 118 around pin 134. Thecorneal implant (not shown in FIGS. 7 and 8 for clarity) is disposedbetween the moderate body and the minimal body in a nest formed by themoderate and minimal bodies. Second portion 120 is adapted to rotatewith respect to first portion 118 around pin 134. FIG. 9 (sectional sideview) illustrates the device after actuator 116 has been pressed down.When actuator 116 is pressed, spring 126 is compressed, and distalsection 128 moves forward, or distally, through the channel in distalportion 114. The distal end of distal section 128 makes contact withsecond portion 120, forcing it downward as it rotates around pin 134.Because the corneal implant has a higher affinity for moderate body 122than minimal body 124, the corneal implant will remain adhered tomoderate body 122 as second portion 120 and minimal body 124 are rotatedaway from first portion 118 and moderate body 122. Once the curvedportion of second portion 120 clears pin 134, second portion 120 isdetached from first portion 118 and therefore from device 100, preparingthe corneal implant for delivery (or, in some embodiments the cornealimplant is delivered using a separate delivery device).

FIG. 10 illustrates a perspective view of the distal region of device100. First portion 118 is secured to second portion 120 with clip 132,which is biased to the closed configuration shown in FIG. 10. Upon theapplication of the actuation force from actuator 116, clip 132 is forcedinto an open configuration, allowing second portion 120 and minimal body124 to be rotated away from first portion 118.

FIG. 11 illustrates a sectional side view of the distal portion of thedevice. FIG. 12 shows the sectional side view from FIG. 11 afteractuator 116 has been actuated and second portion 120 is rotating awayfrom first portion 118. Corneal implant 140 remains adhered to moderatebody 122 due to the higher affinity of the moderate body. FIG. 13illustrates a side view after second portion 120 has been completelydisengaged from first portion 118. Actuator 116 is then released tocause distal section 128 to retract back into distal portion 114.Corneal implant 140 is now ready for delivery and can be delivered asdescribed above. In some embodiments the corneal implant is positionedagainst stromal corneal tissue, and because the inlay has a higheraffinity to the corneal tissue than to the moderate body, the inlay willdisassociate from the moderate body and adhere to the corneal tissue.

FIGS. 14A-14D illustrate an exemplary embodiment of minimal and moderatebodies, which can be incorporated into the assembly from FIGS. 7-13.Minimal body 224 includes recess 225 formed therein such that whenmoderate body and minimal body are moved towards one another, they forma nest in which the inlay is retained (see FIG. 14D). The recess has agenerally circular configuration (similar to the general configurationof minimal body 224), but other configurations may be suitable. Recess225 is adapted to accommodate the corneal implant within the recess.Recess 225 is also sized to prevent inlay 140 (see FIGS. 14B-14D) frombeing compressed between the minimal and moderate bodies while beingshipped or stored (see FIG. 14D). The corneal implant is thereforemaintained in substantially unstressed, or non-deformed, configuration.Because the inlay has a defined curvature, it may be preferred to notallow the inlay to be distorted during shipping and/or storage, and therecess (and thus the nest) can be sized to help prevent it from beingdistorted. Additionally, because of the fluidic nature of some inlays,it can be difficult to constrain the inlay laterally between twoparallel surfaces without the presence of a recess. The recess formed inthe minimal body allows for easy containment without excess force beingapplied to the inlay. The nest formed by the moderate and minimal bodiesprevents compression and/or damage to the inlay while acting as astorage compartment.

As can be seen in FIGS. 14B-14D, the recess size is larger than theinlay size. Particularly, in this embodiment, the diameter of the recess(“dr”) is greater than the diameter of the inlay (“di”). Additionally,the diameter of the moderate body (“dM”) is greater than the diameter ofthe recess (“dr”) formed in the minimal body (see FIG. 14D). Thediameter of the minimal body (“dm”) is greater than the diameter of themoderate body (“dM”).

The depth of the recess is greater than the material thickness of theinlay, but is preferably slightly less than the height of the cornealimplant in a non-stressed configuration. This ensures that at least aportion of the corneal implant is maintained in contact with both themoderate body and the minimal body. If at least a portion of the cornealimplant is not in contact with the moderate body, the corneal implantcan remain adhered to the minimal body rather than the moderate bodywhen the moderate and minimal bodies are moved away from one another. Inan exemplary embodiment the material thickness of the corneal implant isabout 38.1 microns, the overall height of the implant in a non-stressedconfiguration is about 152.4 microns, and the depth of the recess isbetween about 63.5 microns and about 114.3 microns.

Similar to the embodiment in FIGS. 7-13, moderate body 222 is secured tofirst portion 218, while minimal body 224 is secured to second portion220. The system is used in the same manner as the embodiment in FIGS.7-13.

In some exemplary embodiments of the systems shown herein (e.g., thosein FIGS. 7-14D), the moderate body is stainless steel. In someembodiments it can be about 0.1 mm thick. As shown in the figures, theplurality of openings in the moderate body have general hexagonconfigurations. In some exemplary embodiments the dimension from a firstside of the hexagon to a second side that is parallel to the first side(i.e., double the hexagon's apothem) of at least a substantial number ofthe hexagon shapes is about 0.35 mm. In some embodiments that dimensioncould be between about 0.02 mm to about 0.12 mm. The distance betweenhexagons (i.e., the distance from a first side of a first hexagon to afirst side of a second hexagon, wherein the sides are parallel to oneanother and the hexagons are directly adjacent to one another) is about0.05 mm, although this distance could be between about 0.01 mm and about0.25 mm. The diameter of the moderate body can be about 3 mm, but insome embodiments it is between about 0.25 mm and about 13 mm. The abovenumerical limitations are merely exemplary and not intended to belimiting.

In some exemplary embodiments of the systems shown herein (e.g., thoseshown in FIGS. 7-14D), the minimal body is stainless steel, and is about0.2 mm thick, except in the recess section. As shown in the figures, theopenings in the minimal body each have general hexagon configurations.In some exemplary embodiments the dimension from a first side of thehexagon to a second side that is parallel to the first side (i.e.,double the hexagon's apothem) of at least a substantial number of thehexagon shapes is about 1 mm. In some embodiments that dimension couldbe between about 0.1 mm to about 3 mm. The distance between hexagons(i.e., the distance from a first side of a first hexagon to a first sideof a second hexagon, wherein the sides are parallel to one another andthe hexagons are directly adjacent to one another) can be about 0.2 mm,although this distance could be between about 0.02 mm to about 0.12 mm.The diameter of the minimal body can be about 6.5 mm, but in someembodiments it is between about 3 mm and about 13 mm. The abovenumerical limitations are not intended to be limiting.

In some embodiments the diameter of the minimal body is at least about 2times the diameter of the moderate body. In some embodiments thediameter of the minimal body is at least about 1.5 times the diameter ofthe moderate body. In some embodiments the size of the plurality ofhexagons in the minimal body is at least about 2 times the size of theplurality of hexagons in the moderate body. In some embodiments theycould be at least about 3 times, or at least about 4 times.

FIGS. 15-18 illustrate additional views illustrating the relative sizesand dimensions of the mesh bodies and a corneal inlay. In thisembodiment the inlay has a diameter of about 2 mm. FIG. 15 is a top viewillustrating minimal mesh body 224, recess 225 formed in minimal meshbody, periphery of inlay 140, and the surface area 240 (shown in hashlines) of minimal body 224 that overlaps with the inlay when the inlayis positioned in recess 225. In this particular embodiment surface area240 of minimal body 224 that overlaps with the inlay is about 0.9 mm².The perimeter of the inlay that overlaps the minimal body is about 9 mm.FIG. 16 illustrates minimal mesh body 224 and periphery of inlay 140,and the surface area 242 (shown in hash lines) of openings 244 (onlythree openings 244 labeled) that overlaps the inlay when the inlay is inthe recess. In this particular embodiment the surface area 242 is about2 mm².

FIG. 17 illustrates moderate mesh body 222 and the periphery of inlay140 disposed thereon. Surface area 250 of moderate body 222 is thesurface area of the moderate body that overlaps the inlay, at least aportion of which is in contact with the inlay, when the inlay ispositioned in the nest. In this particular embodiment surface area isabout 0.75 mm². The perimeter of the inlay is about 26 mm. FIG. 18illustrates moderate body 222, periphery of inlay 140, and the surfacearea 254 (shown in hash lines) of openings 252 (only three openings 252are labeled) that overlap the inlay. Surface area 254 is about 2.3 mm².

In some embodiments the moderate body and the minimal body each have oneor more openings, or apertures, extending through the bodies. The ratioof the moderate aperture perimeter (or sum of the aperture perimeters ifmore than one aperture) to the moderate aperture area (or sum of theapertures areas if more than one aperture) is greater than the ratio ofthe minimal aperture perimeter (or sum of the aperture perimeters ifmore than one aperture) to the minimal aperture area (or sum of theaperture areas if more than one aperture). Without necessarily wishingto be bound by a particular theory, the greater ratio results in greaterforces being applied to the corneal implant from the moderate body thanthe minimal body, and thus provides the moderate body with a higheraffinity for the corneal implant than the minimal body. When themoderate and minimal bodies are moved apart relative to one another, thegreater forces applied to the implant will cause the implant to remainadhered to the moderate body rather than the minimal body.

By way of illustration only, in the embodiments shown in FIGS. 15-18,the sum of the perimeters of the apertures in the moderate body thatoverlap the implant were determined to be about 1.03 in, while the sumof the aperture areas that overlap the implant were determined to beabout 0.0012 in². The ratio of perimeter to area for this particularmoderate body was about 858 in⁻¹. The sum of the perimeters of theapertures in the minimal body that overlap the implant were determinedto be about 0.365 in, while the sum of the aperture areas that overlapthe implant were determined to be about 0.0014 in². The ratio ofperimeter to area for this particular moderate body was about 260 in⁻¹.The ratio is therefore greater for the moderate body than for theminimal body.

FIG. 19 is a partial exploded view of an exemplary corneal implantstorage and positioning device. Positioning device 310 generallyincludes a handle assembly 312 that includes the moderate body, supportassembly 314 that includes the minimal body, and actuator assembly 316that is adapted to actuate, or move, support assembly 314 with respectto handle assembly 312. Due to the inlay's greater affinity for themoderate body, the inlay will adhere to the moderate body when thesupport assembly 314 is actuated.

Actuator assembly 316 includes push rod 320 coupled to button 321, andspring 322. Handle assembly 312 includes handle 324 coupled to distalportion 326, which includes the moderate body. The distal end of spring322 is secured within the internal channel within handle 312, and theproximal end of spring 322 is secured to the distal end of button 321.Push rod 320 is configured to be disposed within the internal lumen ofspring 322. As shown in more detail in FIGS. 20A-20C, the distal end ofpush rod 320 includes bore 328 therethrough, adapted to receive dowel318 therein. When push rod 320 has been advanced distally within handleassembly 312 and extends just out of the distal end of handle assembly312, as shown in FIG. 20A, dowel 318 is advanced through bore 328. Dowel318 both prevents push rod 320 from retracting proximally within handleassembly 312, but it also provides base assembly 314 with a surface toengage in order to secure support assembly 314 in place relative tohandle assembly 312, as shown in FIG. 20C. The device also includes rod330, which helps secure support assembly 314 in place relative to handleassembly 312 (see FIG. 20C), but allows support assembly 314 to rotatearound rod 330 when the actuator is actuated. Dowel 318 is also involvedin the actuation of the support assembly. Actuating button 321 causespush rod 320, and thus dowel 318, to be advanced distally within handleassembly 312. This causes dowel 318 to apply a generally distallydirected force to support assembly 314, which causes dowel 318 to pushdown on support assembly 314. Upon the application of this force supportassembly 314 will begin to rotate around rod 330, causing minimal bodymesh 338 to move away from moderate mesh body 334. Further rotation ofsupport assembly 314 will free support assembly 314 from rod 330,allowing support assembly 314 to be completely disengaged from handleassembly 312. Once disengaged, the corneal implant will remain adheredto moderate body 334 and is ready for use, such as delivery into or ontocorneal tissue. Once the minimal mesh body is moved, the user canrelease button 321, and spring 322 causes actuator 316 to return to anat-rest, or non-actuated, position relative to handle assembly 312.

By incorporating rod 330, support assembly 314 rotates with respect tohandle assembly 312 in only one direction, which prevents torqueing.

FIG. 21 is a partial exploded view of handle assembly 312 shown in FIG.17 (actuator and base assembly not shown). Assembly 312 includes handle324, distal tip portion 342, dowel 318, applicator base 336, andapplicator 334. Handle 324 is secured to distal tip portion 342, and thedistal end of distal tip portion 342 is disposed within a bore inapplicator base 336. Applicator 334 is secured to applicator base 336.FIG. 22 shows the assembled view from FIG. 21.

FIGS. 23A-23D illustrate alternative views of the assembly of applicatorbase 336, applicator 334, and rod 330. FIG. 23A is an explodedperspective bottom view. FIG. 23B is a perspective top view illustratinghow rod 330 is disposed within applicator base 336. FIG. 23C is a bottomview showing applicator 334 secured to applicator base 336 and aplurality of attachment points 350 for securing applicator 334 toapplicator base 336. FIG. 23D is a front view showing applicator 34secured to applicator base 336, and rod 330 disposed within applicatorbase 336. Applicator 334 and applicator base 336 can be secured togetherby any suitable technique. In one embodiment applicator 334 is welded tobase 336, such as by resistance welding or laser welding. Applicator 334includes the moderate mesh body.

FIGS. 24A-24I illustrate a variety of views of a particular embodimentof applicator base 336 described above. The internal bore through whichthe actuator extends can be seen in the sectional side view of FIG. 24D.The dimensions indicated in the figures are merely exemplary to thisparticular embodiment and are not limiting.

FIGS. 25A-25C illustrate exemplary dimensions for applicator 334,including the mesh dimensions, described above. For example, dimensionsof the mesh that contribute to implant preference to adhere to themoderate body over the minimal body are shown. FIG. 25A is a top view.FIG. 25B is a side view. FIG. 25C is a detailed view of section A fromFIG. 25A.

FIGS. 26A-26D illustrate support assembly 314 from FIG. 17, whichincludes support base 340 secured to implant support 338. Support base340 and implant support 338 are secured to one another similarly to theapplicator base and the applicator described above. FIG. 26A is anexploded view, while FIG. 26B is an assembled view. FIG. 26C is a topview. FIG. 26D is a detailed view C from FIG. 26A of applicator 338showing recess 360 defined by recess sidewalls 356 and recess basesurface 358. The implant is configured and sized to be disposed withinthe recess such that it is positioned between the minimal and moderatemeshes prior to removal of the minimal body.

FIGS. 27A-27E illustrate front, sectional side, side, and top views ofsupport base 340.

FIGS. 28A-28D illustrate views of the support 338. FIG. 28B illustratessection A-A shown in FIG. 28A. FIG. 28C shows detail B from FIG. 28B,and FIG. 28D shows detail C from FIG. 10A. Recess 360 is formed in a topportion of the support 338. Mesh apertures 364 are defined by body 362,illustrated in FIGS. 28B and 28C. The dimensions shown are exemplary andnot intended to be limiting. The mesh apertures of the minimal body arelarger than the mesh apertures of the moderate body, which is one of thecontributing factors for why in this particular embodiment the implantpreferentially adheres to the moderate body.

In general, the recess in the minimal mesh body should be sized toprevent forces, or a substantial amount of forces, from being applied tothe corneal implant while it is positioned in the nest between themoderate and minimal bodies prior to use.

The mesh apertures and the recess can be created by any suitabletechnique, such as chemical etching, laser cutting, micro water jetcutting, etc. In some instances chemical etching provides for a cleanercut and does not require as much post-manufacture processing of thebody. The mesh apertures can be created from only one side, or in someembodiments half of the thickness of the aperture is created from oneside, while the other half of the aperture is created from the otherside. In some embodiments the recess is etched from one side, while themesh apertures are created in the other side. Any combination orvariation on these techniques can be used. In some embodiments therecess is created by plunge electrical discharge machining (“EDM”).

In general, the net forces acting on the corneal implant are greaterfrom the moderate mesh body than from the minimal mesh body. Thepolarity of water is an important factor when the corneal implant isformed of a hydrophilic material because in these instances the implanthas properties like water and as such behaves like water. The dimensionsof the mesh, configuration of the mesh, mesh body, and other factors canbe modified to alter the relative affinities.

As described above, the minimal mesh body diameter is larger than themoderate mesh body diameter (both are shown to have a generally circularconfiguration). The minimal body diameter, due to its larger size, actslike a bumper, protecting the entire distal region of the apparatusduring storage and use prior to actuation of the actuator. In thespecific example shown above, the minimal body thickness is about twiceas thick as the moderate body.

The moderate body diameter is larger than the recess, while the minimalbody diameter is larger than the moderate body diameter. In someembodiments it may be helpful for the physician to be able to visualizethe pupil when the corneal implant is being positioned in the cornea.For example, this may be desirable when implanting an inlay into thecornea wherein the inlay has a diameter less than the diameter of thepupil, such as a 1-3 mm diameter corneal inlay. For these applicationsthe moderate mesh body can be sized such that it does not interfere withthe visualization of the pupil. Specifically, the moderate mesh bodyportion is sized to allow the physician to be able to see the pupilduring the delivery of the implant on corneal tissue. Starting with thisconstraint, the size of the other components can then be determined.

The use of “diameter” herein is not to suggest that the mesh body outersurfaces are perfectly circular or are circular at all. The two meshportions could be square or rectangular-shaped, with the width andlength of the minimal mesh portion larger than the width and length ofthe moderate mesh portion.

While in the embodiments above the implant's affinity for the moderatebody is described as largely due to the size and configuration of themoderate mesh body relative to the minimal body, there are many ways toestablish and control the implant's affinity for a given body. In someembodiments this can be accomplished by using a moderate body that isdifferent than the minimal body. In some embodiments a finish could beapplied to one or more of the surfaces of the moderate and minimalbodies. The finish can be different on the moderate and the minimal bodyto control the preferential adhesion. In some embodiments the moderatebody has a better finish than the minimal body. In some embodiments theminimal body has a matte finish on it.

One or more components of the devices described herein can be astainless steel or titanium. For example, applicator base 36 andapplicator 34 can both be stainless steel, one can be titanium while theother is stainless steel, or both can be titanium.

FIGS. 29A-29D illustrate views of distal tip 342 from the handleassembly described above. FIG. 29A is a view looking from the proximalend to the distal end, FIG. 29B is a view from the distal end to theproximal end, FIG. 29C is a sectional side view, and FIG. 29D is a frontview. The distal tip is secured to the handle, and the distal end of itis disposed in the applicator base 336.

FIGS. 30A-30E illustrate in detail actuator assembly 316 from FIG. 19.The actuator includes button 321, push rod 320, and bore 328 at thedistal end of push rod 320. FIG. 30A is an exploded view, FIG. 30B is anassembly view, FIG. 30C is a side sectional view of section A-A shown inFIG. 30E, and FIG. 30D is a detail view of section B shown in FIG. 30C.

FIGS. 31A-31D illustrate detailed views of button 321. FIGS. 32A-32Dillustrate detailed views of push rod 320, including bore 328.

FIGS. 33A-33D illustrate detailed views of handle 324. FIGS. 34A and 34Billustrate detailed views of spring 322. FIGS. 35A and 35B illustratedetailed viewed of dowel 18.

Once the corneal implant is loaded in the apparatus between the moderateand minimal bodies, the implant can be used right away or it can bestored in packaging for any suitable period of time. When the cornealimplant is made of a hydrogel material, it is important to keep theimplant adequately hydrated during storage.

Embodiments herein describe both a moderate body and a minimal body. Insome embodiments, however, the apparatus or its method of use need notinclude the minimal body. Without the minimal body, the corneal implantis not positioned within a corneal nest defined by the moderate andminimal bodies. The implant therefore need not be packaged with themoderate body. For example, it can be packaged in a separate packaging.In these embodiments the moderate body can utilize its preferentialadhesion for the implant as set forth above to retrieve, or pick up, thecorneal implant from its packaging. This can eliminate restrictions onhow the cornel implant needs to be packaged. For example, the implantcan be stored in a vial, free-floating in a storage medium. When theimplant is ready to be positioned on the corneal tissue, the moderatebody, which can be coupled to a handle, is positioned adjacent theimplant in its storage medium, such as by scooping up the cornealimplant into a position adjacent the apertures therein. Due to itspreferential adhesion adaptation, the corneal implant willpreferentially adhere to the moderate body. Once it has adhered to themoderate body, the implant is ready to be deposited onto the cornea asset forth above by relying on the moderate body's adaptation to allowthe implant to preferentially adhere to the corneal tissue rather thanthe moderate body.

What is claimed is:
 1. A corneal implant applicator apparatus,comprising a corneal implant applicator comprising a corneal implantapplicator surface with at least one opening therethrough; a cornealimplant support disposed relative to the corneal implant applicator, thecorneal implant support having a corneal implant support upper surfaceand a corneal implant support lower surface, wherein the upper and lowersurfaces have a therethrough; a corneal implant disposed between thecorneal implant applicator and the corneal implant support, wherein thecorneal implant applicator surface and the corneal implant supportsurface are adapted such that the corneal implant preferentially adheresto the corneal implant applicator surface rather than the cornealimplant support surface when the corneal implant support is movedrelative to the corneal implant applicator due to the corneal implant'spreference for adhering to the corneal implant applicator surface ratherthan the corneal implant support surface, and such that the cornealimplant preferentially adheres to corneal tissue rather than the cornealimplant applicator surface when the corneal implant applicator is movedrelative to the corneal tissue due to the corneal implant's preferencefor adhering to the corneal tissue rather than the corneal implantapplicator surface.
 2. The apparatus of claim 1 wherein the cornealimplant support is adapted to be moved relative to the applicator toprovide access to the corneal implant and cause the corneal implant topreferentially adhere to the corneal implant applicator.
 3. Theapparatus of claim 1 wherein the corneal implant comprises a hydrophilicmaterial.
 4. The apparatus of claim 1 wherein the corneal implantsupport is disposed relative to the corneal implant applicator to form acorneal implant chamber.